Emplois actuels liés à Regulatory Affairs Manager Benelux - Brussels - Grünenthal

  • Head of Corporate and Regulatory Affairs Benelux

    Il y a 4 mois

    Brussels, Belgique British American Tobacco Temps plein

    . **BAT is evolving at pace - truly like no other organisation.** **To achieve the ambition, we have set for ourselves, we are looking for colleagues who are ready to live our ethos every day. Come be a part of this journey!** **BAT BELGIUM IS LOOKING FOR A HEAD OF CORPORATE & REGULATORY AFFAIRS BENELUX** **SENIORITY LEVEL**:Senior...

  • Regulatory Policy Officer

    Il y a 5 mois

    Brussels, Belgique VRS Regulatory Temps plein

    An opportunity for a Regulatory Policy Officer to join a global chemical trade association. You will be responsible for supporting all policy-related scientific and regulatory activities in Europe. This role will be diverse, challenging and offer excellent career development. You will primarily be involved in gathering, analysing and disseminating relevant...

  • Junior Regulatory Affairs Manager

    Il y a 3 mois

    Brussels, Belgique Danone Temps plein

    About the job **Are you at the beginning of your regulatory affairs career, looking for a unique opportunity to kick-start it? **Join Danone Belux in **Brussels**, as **Junior Regulatory Affairs Manager**!** You will be a keystone for the Regulatory team in **delivering high quality and pragmatic regulatory advice to **Danone’s Baby nutrition and Medical...

  • Regulatory Affairs Manager

    Il y a 4 mois

    Brussels, Belgique STADA Arzneimittel AG Temps plein

    **About EG** - EG is a Purpose driven company: at the core of everything we do, we aim to Care for People´s Health as a Trusted Partner.- EG is also the largest pharmaceutical company in Belgium. With an offering for just about every therapeutic area, we are the market leader in generic medicines and the biggest OTC company in Belgian pharmacies.- Most of...

  • Senior Regulatory

    Il y a 3 mois

    Brussels, Belgique ENGIE Temps plein

    Requisition ID: 17434- Location: BRUXELLES, BE, 1000**Join Our Team as a Senior Regulatory & Public Affairs Manager (M/F/X)** Are you passionate about shaping the future of energy transition? Do you thrive in a dynamic environment where your expertise can drive positive change? Look no further! **ENGIE Belgium** is actively seeking a **Senior Regulatory &...

  • Senior Director, Regulatory Affairs

    il y a 3 semaines

    Brussels, Belgique Hologic Temps plein

    **As a leading innovator of womens' health, we at Hologic are empowering people to live healthier lives everywhere, every day,** Our regulatory affairs team is responsible for keeping abreast of new, changing and existing regulatory requirements. They lead the development and implementation of a global vision for regulatory affairs to influence strategic...

  • Regulatory Affairs Specialist

    Il y a 4 mois

    Brussels, Belgique SWIFT Financial Messaging Services Temps plein

    About the Role Become part of the Legal & Compliance team The Legal & Compliance team is looking for a Regulatory Affairs Specialist with a strong background in payments, securities, and technology policy. As part of the Regulatory Affairs team, you will take responsibility for financial and technology policy developments around the world, by identifying,...

  • Regulatory Affairs Europe Manager

    Il y a 3 mois

    Brussels, Belgique Unilever Temps plein

    UNILEVER IS LOOKING FOR A PERSONAL CARE REGULATORY AFFAIRS EUROPE MANAGER Full-time Local conditions apply ABOUT UNILEVER Unilever is one of the world's largest Fast Moving Consumer Goods (FMCG) businesses, with interest across Personal Care, Homecare, Refreshment and Foods product categories. We reach 2 billion consumers a day. It has 161,000 employees....

  • Regulatory Affairs Specialist

    Il y a 4 mois

    Brussels, Belgique Luminus Temps plein

    Als Junior Regulatory Affairs Manager maak je deel uit van de **Corporate Affairs** afdeling. De afdeling Corporate Affairs staat centraal in de relaties van Luminus met overheden, toezichthouders en besluitvormers. Het departement vergemakkelijkt de uitwisselingen tussen deze instellingen en de operationele activiteiten van Luminus, dient als interface om...

  • Regulatory Affairs Specialist

    il y a 3 semaines

    Brussels, Belgique Sasmar Pharmaceuticals Temps plein

    **Description**: SASMAR is currently seeking a highly motivated and detail-oriented individual to join our team as a Regulatory Affairs Specialist. With our headquarters based in Brussels, Belgium, and operations in Sydney, Hong Kong, Mumbai, Malta, London, and Chicago, we are a fast-growing pharmaceutical company that specializes in personal care and...

  • Regulatory Affairs Officer

    Il y a 4 mois

    Brussels, Belgique Pauwels Consulting Temps plein

    In het kortbrussel / bruxelles bediende, freelancer 40 uur per week - Amandine JansenTalent Acquisition Lead Life Sciences 0032491153475 - **Regulatory Affairs Officer**: Pharma & Sciences - Regulatory Affairs - Compile and maintain regulatory documentation databases or systems - Coordinate efforts associated with the preparation of regulatory documents or...

  • Regulatory Affairs Officer

    Il y a 3 mois

    Brussels, Belgique Pauwels Consulting Temps plein

    In het kortbrussel / bruxelles bediende, freelancer 40 uur per week - Amandine JansenTalent Acquisition Lead Life Sciences 0032491153475 - **Regulatory Affairs Officer**: - Pharma & Sciences - Regulatory Affairs - Compile and maintain regulatory documentation databases or systems - Coordinate efforts associated with the preparation of regulatory documents...

  • Junior Scientific and Regulatory Affairs Manager

    il y a 3 jours

    Brussels, Belgique PROFEL - European Association of Processed Fruit and Vegetables Temps plein

    **Job Category**: **European Union** **Job Experience**: **None** **Job Location**: **Brussels** **Expiration Date**: **03 Oct 2024** PROFEL is the **European Association of Fruit and Vegetable Processing Industries.** As part of the Brussels team, **PROFEL is recruiting a junior Scientific and Regulatory Affairs Manager.** The junior Scientific and...

  • Regulatory Affairs Officer

    Il y a 3 mois

    Brussels, Belgique STADA Arzneimittel AG Temps plein

    **About EG** - EG is a Purpose driven company: at the core of everything we do, we aim to Care for People´s Health as a Trusted Partner.- EG is the largest pharmaceutical company in Belgium.- With an offering for just about every therapeutic area, we are the market leader in generic medicines and the biggest OTC company in Belgian pharmacies.- Most of our...

  • Head of Quality and Regulatory Affairs

    Il y a 4 mois

    Brussels, Belgique SASMAR Temps plein

    SASMAR is currently seeking a highly skilled and experienced individual to join our team as the Head of Quality and Regulatory Affairs. With our headquarters based in Brussels, Belgium, and operations in Sydney, Hong Kong, Mumbai, Malta, London, and Chicago, we are a fast-growing pharmaceutical company that specializes in personal care and fertility...

  • Head of Quality and Regulatory Affairs

    il y a 3 semaines

    Brussels, Belgique Sasmar Pharmaceuticals Temps plein

    **Description**: SASMAR is currently seeking a highly skilled and experienced individual to join our team as the Head of Quality and Regulatory Affairs. With our headquarters based in Brussels, Belgium, and operations in Sydney, Hong Kong, Mumbai, Malta, London, and Chicago, we are a fast-growing pharmaceutical company that specializes in personal care and...

  • Regulatory Affairs Liaison Oncology

    Il y a 4 mois

    Brussels, Belgique MSD Temps plein

    Do you want to be part of our Oncology division, helping people fight cancer, supporting accessibility to our cancer medicines, and pursuing research in immuno-oncology to bring new hope to people with cancer? We have a new, exciting opportunity for a **Regulatory Affairs Liaison Oncology (Associate Principal Scientist) **to be based in Oss (NL), Brussels...

  • Assoc Regulatory Affairs Spec

    Il y a 3 mois

    Brussels, Belgique Medtronic Temps plein

    **Careers that Change Lives** Bold thinking. Bolder actions. We are Medtronic. We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 90,000+ passionate people. Powered...

  • Regulatory Affairs Specialist

    Il y a 4 mois

    Brussels, Belgique Amaris Consulting Temps plein

    **Who are we? **:**Amaris Consulting** is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1,000 clients across the globe, we have been rolling out solutions in major projects for over a decade - this is made possible by an international team of 7,600 people spread across 5 continents and more than 60...

  • Regulatory Affairs Assistant

    Il y a 3 mois

    Brussels, Belgique Staphyt Temps plein

    Entreprise :We strengthen science together!Present in Europe, North Africa, South America, STAPHYT brings together more than 700 employees, of different nationalities and cultures. Rich in multiple profiles, a wide range of expertise is expressed in the Group, through our areas of activity which are agronomic experimentation, regulatory advice and...

Regulatory Affairs Manager Benelux

Il y a 4 mois

Brussels, Belgique Grünenthal Temps plein

**Country**:Belgium**City**:Brussels**Department**:Research & Development**Job ID**:43270**Hiring Manager**: Mirjam van de Wiel- If you’re passionate about changing lives for the better, this is the opportunity you’ve been waiting for. In
- **Research & Development**, we’re continuously exploring innovative new treatment options to make a stronger, more positive impact on the lives of the patients we serve. You’ll work with talented colleagues in a state-of-the-art Research & Development environment, developing innovative medicines that change the live of patients for the better and help us make progress towards our vision of a world free of pain. Join us today, and discover the difference you can make.**What the job looks like**
Each day, you’ll enjoy a variety of challenges such as:
**50% Regulatory Affairs (BeNeLux)**:
Manage the regulatory activities for licenses in the BeNelux in accordance with the European and national requirements and Grünenthal (GRT) standards.- Manage Marketing Authorizations and ensure marketed products fulfill all requirements:

- Perform local regulatory activities to obtain marketing authorizations for pharmaceutical products, and maintain the MA by submitting the required variations. (Most products are registered via MRP/DCP or via national procedures, some via CP.)
- Arrange transfer and launch of newly acquired products.
- Manage and check local translations of SmPC, package insert and labelling in national languages.
- Interact with local authorities and headquarters to support product approval and compliance and ensure that enquiries from local authorities are handled in a serious and timely manner.
- Initiate, check and approve artwork changes and ensure timely implementation.
- Create/translate and implement additional Risk Minimization Measures (e.g. educational material) if applicable.
- Ensure submission of all notifications in compliance with local legislation and guidelines.
- Internal processes and support:

- Provide updated realistic timelines to the local organization for the approval and availability of new products and relevant changes of existing products (e.g. new indications, line extensions, reformulations).
- Ensure that updated local legislation and guidelines are available and interpreted for the use of project teams and other relevant GRT employees (both locally and in HQ).
- Be aware of and highlight regulatory opportunities and identify issues and problems, and recommend solutions through the reporting lines.
- Provide input to the strategic review of product portfolio at GRT in close association with the cross-functional teams.
- Ensure that relevant processes are described in SOPs or other structured documents, and reviewed and updated accordingly.
- Ensure that an overview of the registration status for all products is maintained in the BeNeLux, including the tracking of all submissions and commitments.
- Review of promotional and non-promotional materials
- Ensure compliance of promotional and non-promotional materials with local pharma codes. Interact with marketing and medical to support creation of compliant materials.
- Clinical trials:
**50% Regulatory Affairs Label Compliance (EU/Global)**:

- Support Regulatory Affairs procedures in place to comply to the Global Label Management Process ensuring worldwide / regional consistency and governance- Provide functional support to maintain and develop regulatory labeling-related systems, processes and compliance activities.
- Routinely support the RA Compliance Lead / Labeling in the process of providing end-to-end (E2E) oversight of the Global Label Process to the Global Label Management Board (GLMB) with data continuity and tracking across all functions involved (e.g. Development, Pharmacovigilance, Regulatory Affairs, Medical Affairs, Artwork, Supply Chain and Quality)
- Support and manage the process of escalation of labeling issues (e.g. delays in timeline, content deviations) to the GLMB according to the Global Label Process. This includes reporting to the GLMB secretary safety relevant information on the Global Label Process performance deviations.
- Ensure the LMB secretary role for all core and non-core products and the setting up of the meeting calendar, documentation and archiving as well as functional support.
- Maintain in-depth knowledge of relevant SOPs, laws, regulations and guidelines relevant to regulatory labeling and cross functional projects that impact compliance.
- Support the cross functional projects that impact label compliance.
- Partner with affiliates to promote local compliance with labeling policies and standards supporting in the review of local process/standard procedural documents, describing the processes followed locally or reference to use of global procedures, in accordance with local regulations and in alignment with GRT Group procedures, as required.
- Support Global Label Process training in GRT.
- Support appropriate filing and archiving of the